Kornimate/medical-research-clean huggingface dataset:
efficacy and safety of oms103hp in patients undergoing allograft anterior cruciate ligament (acl) reconstruction

Conditions: Knee Injuries

Summary: the anterior cruciate ligament (acl) is an important stabilizer of the knee. orthopedic surgeons replace the torn ligament during acl reconstruction surgery. surgical trauma initiates an acute inflammatory response, including swelling and pain, that leads to restricted joint motion and loss of function. oms103hp was designed to deliver targeted therapeutic agents directly to the surgical site during the arthroscopic procedure to inhibit inflammation and pain before they can begin. the purpose of this study is to assess the effectiveness and safety of oms103hp in improving knee function following acl reconstruction. secondary benefits being evaluated include reduced postoperative pain, improvement in knee range of motion and earlier return to work.


Eligibility criteria:
inclusion criteria: * 15 - 65 years of age * in good general health with an acl tear that occurred from 2 weeks to 18 months prior to the day of arthroscopic surgery * undergoing primary unilateral acl reconstruction using an allograft (patellar tendon bone, achilles tendon, tibialis tendon, or hamstring) * able to participate in the study rehabilitation protocol * and other inclusion criteria exclusion criteria: * no allergies to any of the individual ingredients in oms103hp * no medications with the same activities as that of the active ingredients in oms103hp for defined time intervals prior to and after surgery * no associated knee injuries likely to interfere with evaluation of the study drug * and other exclusion criteria

Keywords: anterior cruciate ligament reconstruction acl reconstruction
dietary wild blueberries and joint health

Conditions: Gut -Microbiota; Inflammation Biomarkers; Pain Assessment; Joint Pain

Summary: the goal of this proposed study is to examine the effects of dietary wild blueberries on gut microbiome, serum markers of inflammation, and joint function in adults. each participant will consume 25g freeze-dried blueberries or matched placebo powder for 12 weeks, with a 2-week washout phase between.


Eligibility criteria:
inclusion criteria: * adults with documented multi-joint/knee arthritis exclusion criteria: * inability to give informed consent * pregnancy or lactation * planned knee replacement surgery * allergy or contraindication to berries * recent trauma of the knee responsible of the symptomatic knee * intra-articular injection in the target knee/hip in the last 3 months * oral corticosteroid therapy ≥ 5 mg/day (prednisone equivalent) at baseline * use of berry extracts in the last 3 months * special diets * cancer treatment * bone diseases
intestinal sweet taste receptor function and adaptation to dietary sugars and sweeteners

Conditions: Diabetes

Summary: the purpose of this study is to collect data that will help researchers better understand the various causes of obesity and diabetes; particularly to understand how consumption of ncass affects the way the body uses nutrients.


Eligibility criteria:
inclusion criteria: 1. age 18-65 years inclusive; 2. men and women; 3. able to provide written, informed consent; 4. weight stable (± 3 kg) during the 3 months prior to enrollment; 5. bmi ≤ 25 kg/m2 exclusion criteria: 1. diagnosed with any of the following co-morbidities: a) coronary artery disease, angina or heart failure, b) diabetes, c) bleeding disorders, d) infections, e) hepatitis and/or cirrhosis, f) severe asthma or chronic obstructive pulmonary disorder, g) renal insufficiency, h) bariatric surgery, i) inflammatory bowel disease or malabsorption, j) cancer within the last 3 years (except non-melanoma skin cancer or treated cervical carcinoma in situ), k) psychiatric or eating disorders, l) untreated or inadequately controlled thyroid or other endocrine disorders, m) active rheumatoid arthritis or other inflammatory rheumatic disorder; 2. consumption of more than a can of diet beverage or a spoonful of non-caloric artificial sweeteners weekly (or each equivalent from foods) during the past month. 3. pregnant or nursing women; 4. current smokers (smoking within the past 3 months); 5. known hypersensitivity to saccharin, lactisole, and acetaminophen or any of its exipients; 6. history of difficult blood sample collections or unfavorable anatomy of venous access; 7. use of medications: a) nitrates, b) beta-blockers, c) digoxin, d) anti-diabetic agents, e) oral, injected or chronic topical steroids (inhaled steroids for mild asthma are acceptable), f) chronic use of aspirin or other non-steroidal anti-inflammatory drugs, g) other drugs known to affect immune or metabolic function and h) orlistat, phentermine or other weight loss or anorectic agents. 8. blood pressure greater than or equal to 160/100 or less than or equal to 100/50 at screening.

Keywords: obesity, sweet taste receptors
meal delivery and exercise

Conditions: Frailty

Summary: the purpose of this study is to evaluate the effects of a home-based exercise program administered through meals on wheels (mow) on gait speed and frailty status and to assess the association between novel serum biomarkers (70 kilodalton heat shock proteins (hsp70),macrophage inflammatory proteins(mip1b), soluble il-6 receptor alpha-chain (sil-6r)) and established but non-specific frailty biomarkers (interleukin 6 (il-6), c-reactive protein (crp), tumor necrosis factor (tnf-α)) in frail and prefrail homebound older adults before and after the exercise intervention.


Eligibility criteria:
inclusion criteria: * homebound (normally unable to leave the home unassisted) * frail or prefrail by the fried frailty phenotype (ffp) * medically stable exclusion criteria: * robust by ffp * have mini-cog score \<3 and/or are unable to follow instructions * have a pre-diagnosed terminal illness * unable to ambulate * unable to use their upper extremities, and/or are already participating in physician-prescribed physical therapy or occupational therapy.

Keywords: homebound patients exercise nutrition
novel adoptive cellular therapy with sars-cov-2 specific t cells in patients with severe covid-19

Conditions: COVID-19

Summary: the overall objective of this project is to develop an emergent treatment protocol using adoptive t-cell therapy for the treatment of severe covid-19. the central hypothesis is that sars-cov-2 specific t cells from convalescent donors who have recovered from covid-19 can be manufactured expeditiously for the treatment of severe sars-cov-2 infections.

a novel severe acute respiratory syndrome coronavirus 2 (sars-cov-2) is the cause of coronavirus disease 2019 (covid-19). currently, no vaccine or specific treatment has been proven to be effective. while waiting for vaccine to be developed, passive immunity can be acquired immediately by adoptive transfer of sars-cov-2 specific t cells from convalescent donors into newly infected patients. the aim of this protocol is to demonstrate the feasibility of preparing sars-cov-2 specific t cells from convalescent donors for urgent clinical use. the specific hypothesis is that sars-cov-2 specific t cells can be isolated from the blood of convalescent donors rapidly and efficiently using sars-cov-2 specific peptides and an automated medical device for emergent treatment of severe covid-19 disease. a minimum of 8 convalescent donors will be recruited from singapore to attain hla sharing with at least 90% of the general population.

Eligibility criteria:
inclusion criteria: * age 21 to 65 * had a history of covid-19 with documented positive test for sars-cov-2 in the past * has recovered from covid-19 and is now suitable for blood donation, fulfilling all standard blood donor criteria * negative test for sars-cov-2 currently exclusion criteria: * do not meet the standard criteria for blood cell donation at national university hospital or singapore general hospital.

Keywords: sars-cov-2 coronavirus disease
the distal-2 study: docetaxel alone or in combination in second-line treatment of advanced non small-cell lung cancer

Conditions: Advanced Non-Small Cell Lung Cancer

Summary: the purpose of this study is to compare the overall survival of patients with advanced non small cell lung cancer treated with docetaxel as single therapy versus docetaxel in combination with either gemcitabine or vinorelbine or in combination with capecitabine.

this study is for patients with previously diagnosed advanced non small cell lung cancer (nsclc, stage iiib or iv) who had progression of their disease during or after first-line therapy containing platinum. patients will be assigned to receive 6 cycles of therapy from one of four treatment regimens: * docetaxel * docetaxel + vinorelbine * docetaxel + gemcitabine * docetaxel + capecitabine

Eligibility criteria:
inclusion criteria: * written informed consent * age \> 18 * histological diagnosis of non small-cell lung cancer (nsclc) * stage iiib or stage iv disease (in iiib, previous treatment with chemotherapy + radiotherapy, or metastatic supraclavicular lymph nodes or pleural effusion) * disease in progression * previous chemotherapy with platinum-derivative (and with \> 21 days from last administration) exclusion criteria: * ecog performance status \> 2 * age \> 75 years * history of malignant neoplasm within the previous 5 years (except for baso- or spino-cellular skin carcinoma and in-situ carcinoma of the uterine cervix, provided they are being adequately treated) * previous treatment with docetaxel * presence of symptomatic cerebral metastasis * neutrophils \ 10g/dl * bilirubin \< 1.5 x the upper normal limit * sgot , sgpt, or bilirubin \> 1.25 x the upper normal limits except in the presence of hepatic metastasis * creatinine \>1.25 x the upper normal limit * any concomitant pathology that would, in the investigator's opinion, contraindicate the use of the drugs in the protocol * inability to comply with follow up * pregnant or nursing females

Keywords: second line monochemotherapy combination chemotherapy platinum refractory previously treated
impact of dietary fiber supplementation on colonic microbiome

Conditions: Benign Colorectal Neoplasm; Non-Neoplastic Anal Disorder

Summary: this clinical trial tests whether daily fiber supplementation will change the mucosal microbiome of the colon. the microbiome are microorganisms that live in the human gut. they serve a vital role in maintaining health. certain microbial strains are associated with the growth of colon polyps, which eventually could go on to form colon cancer. giving dietary fiber supplements may help prevent precancerous polyps from ever developing.

primary objective: i. to identify how diet, specifically fiber supplementation, alters the microbiome of the colonic mucosa. outline: patients receive dietary fiber orally (po) once daily (qd) for 28 days. patients may undergo standard of care proctoscopy or anoscopy with biopsy on study and at follow up or may undergo standard of care colonoscopy on study. all patients also undergo collection of blood samples on study and at follow up.

Eligibility criteria:
inclusion criteria: * age \>= 18 years * ability to understand and the willingness to sign a written informed consent document * patients who present with a chief complaint of a benign anorectal pathology including hemorrhoids, anal fissures, and anal fistulas without underlying conditions such as colorectal cancer or crohn's disease or are undergoing a standard of care colonoscopy procedure exclusion criteria: * patients with an active malignancy, crohn's disease, ulcerative colitis, and immunosuppressed patients * patients with hereditary colon cancer syndrome including lynch syndrome or familial adenomatous polyposis (fap) * patients with a prior history of total or partial colon resection * colorectal pathology, such cancer or proctitis, after initial study scope
left bundle branch block (lbbb) after intuitytm

Conditions: Aortic Valve Disease

Summary: this study aimed to evaluate incidence, prognosis and predictive factors of new-onset of persistent left bundle branch block (lbbb) after rapid-deployment aortic valve replacement (rd-avr) with the intuitytm bioprosthesis. it was an observational, retrospective and single-center study. two hundred and seventy-four consecutive patients without any baseline ventricular conduction disorder or previous permanent pacemaker or defibrillator implantation who underwent rd-avr with the intuitytm valve were included. twelve-lead electrocardiogram and transthoracic echocardiography were performed preoperatively, postoperatively, at discharge, 1-month, and 1-year. incidence, prognosis and predictive factors of new-onset of persistent lbbb were evaluated.


Eligibility criteria:
inclusion criteria: * rapid-deployment aortic valve replacement (rd-avr) with the edwards intuity™ bioprosthesis for severe aortic valve stenosis * between july 2012 and may 2018 exclusion criteria: * preoperative permanent pacemaker or defibrillator, * complete intraventricular conductive disorder defined by a qrs width ≥ 120 ms. * absence of patient's authorization for anonymous publication of their clinical data for research purposes.
a study of patients with lower extremity acute limb ischemia to remove thrombus with the indigo aspiration system

Conditions: Lower Extremity Acute Limb Ischemia; LE ALI

Summary: the primary objective of this study is to collect safety and performance data on the indigo aspiration system in a patient population with lower extremity acute limb ischemia (le ali).


Eligibility criteria:
inclusion criteria: * patient age ≥ 18 * patient presents with acute (≤14 days) occlusion of lower limb artery(ies) (below inguinal ligament) * patient with a rutherford category iia or iib score * frontline treatment with indigo aspiration system * informed consent is obtained from either patient or legally authorized representative (lar) exclusion criteria: * life expectancy \<1 year * vessel size \<2 mm * le ali secondary to dissections, vasculitis, and/or target vessel trauma * amputation in the ipsilateral limb * pregnancy or positive pregnancy test according to site specific standards of care (only required for women of child bearing potential, serum or urine acceptable) * absolute contraindication to contrast administration * patient is unwilling or unable to comply with protocol follow up schedule and/or based on the investigator's judgment the patient is not a good study candidate * currently participating in an investigational drug or device clinical trial that may confound the study endpoints. patients in observational, natural history, and/or epidemiological studies not involving intervention are eligible.
fluoroav45 imaging research-in alzheimer's disease

Conditions: Alzheimer's Disease; Mild Cognitive Impairment

Summary: rationale: improving the early detection of ad at prodromal pre-dementia stages has become a major matter of concern. there is now an important body of literature stating that early isolated cognitive deficits (mild cognitive impairment-mci-) predict the risk of developing ad. several biomarkers are now available : specific and sensitive neuropsychological assessments, morphometric evaluation of hippocampal volume and white matter changes by mri, cerebrospinal fluid or plasma dosage of ab fragments and tau proteins, assessment of brain glucose hypometabolism in temporo-parietal regions with pet \[f18\]fdg. however, pet imaging using labelled compounds specifically binding to aps has been suggested to improve the diagnostic reliability and to potentially help in shortening the delay until formal clinical diagnosis of ad. f18 av45 is a new radiotracer which kinetics characteristics allows 10 to 15 minutes acquisition 50 to 60 minutes post injection. objectives: the primary objective of the study is to compare f18 av45 cortical uptake in ad, mci patients and healthy controls. secondary objectives will be to compare cortical uptake of f18 av45 in mci subject who will have convert toward dementia versus those who will not, at two year follow-up period, to compare level of 18f-av45 cortical uptake with neuropsychological testing, pet fdg hypometabolism, apoe genotype. method: prospective multicentric study. 65 patients expected to enter the study. primary outcome measure: standard uptake volume ratios.


Eligibility criteria:
inclusion criteria: * patients suffering from alzheimer's disease (nincds-adrda) or from amnesic mci * 18 \< mms \<= 28 for patients * 28 \<= mms for healthy volunteers * study period \> 7 years * native language : french * signed informed consent * affiliated to a social security system exclusion criteria: * alcoholism in medical history * diabetes * arterial hypertension (180/100 and more) * chronical pulmonary disease with hypoxis * cranial traumatism with loss of consciousness \> 15 minutes * severe depressive syndrome or anxiety * psychiatric disease in medical history (excepted simple episodes of depression)
assessment of the safety, efficacy, pk, and extrapulmonary pharmacodynamics (pd) of albuterol sulfate pressurized inhalation suspension (hereafter referred to as as mdi) compared to proventil as an active control in subjects with asthma

Conditions: Asthma

Summary: this is a randomized, cumulative dose, open-label, 2-period crossover, multi-center study to assess the safety, efficacy, pk, and extrapulmonary pd of cumulative doses of as mdi compared to cumulative doses of proventil as an active control in subjects with mild to moderate asthma

this is a randomized, cumulative dose, open-label, 2-period crossover, multi-center study to assess the safety, efficacy, pk, and extrapulmonary pharmacodynamics (pd) of cumulative doses of albuterol sulfate pressurized inhalation suspension (hereafter referred to as as mdi) compared to cumulative doses of proventil® hydrofluoroalkane (hfa; hereafter referred to as proventil) as an active control in subjects with mild to moderate asthma.

Eligibility criteria:
inclusion criteria: * have stable (for 6 months) physician-diagnosed asthma with historical documentation of the diagnosis * must be receiving 1 of the following required inhaled asthma therapies listed below for at least the last 30 days; only saba, which is used as needed for rescue, or low to medium doses of ics (alone or in combination with laba), used regularly as maintenance asthma therapy * demonstrate acceptable spirometry performance (ie, meet american thoracic society \[ats\]/european respiratory society \[ers\] acceptability/repeatability criteria * pre-bronchodilator fev1 of ≥50 to \<80% predicted normal value after withholding saba ≥6 hours * confirmed fev1 reversibility to ventolin, defined as a post-ventolin increase in fev1 of ≥15% * only 2 reversibility testing attempts are allowed exclusion criteria: * chronic obstructive pulmonary disease or other significant lung disease (eg, chronic bronchitis, emphysema, bronchiectasis with the need of treatment, cystic fibrosis, or bronchopulmonary dysplasia) * oral corticosteroid use (any dose) within 6 weeks * received any marketed (eg, omalizumab, mepolizumab, reslizumab) or investigational biologic within 3 months or 5 half-lives, whichever is longer, or any other medication specifically prohibited by the protocol * current smokers, former smokers with \>10 pack-years history, or former smokers who stopped smoking \<6 months (including all forms of tobacco, e-cigarettes \[vaping\], and marijuana) * life-threatening asthma as defined as any history of significant asthma episode(s) requiring intubation associated with hypercapnia, respiratory arrest, hypoxic seizures, or asthma-related syncopal episode(s) * historical or current evidence of a clinically significant disease * cancer not in complete remission for at least 5 years * hospitalized for psychiatric disorder or attempted suicide within 1 year * unable to abstain from protocol-defined prohibited medications during the study
an extension study of ataluren (ptc124) in participants with nonsense mutation dystrophinopathy

Conditions: Muscular Dystrophy, Duchenne; Muscular Dystrophies; Muscular Disorders, Atrophic; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Genetic Diseases, X-Linked; Genetic Diseases, Inborn

Summary: the primary objective of this study is to obtain long term safety data of ataluren in male participants with nonsense mutation dystrophinopathy (who participated and completed a previous phase 3 study of ataluren \[ptc124-gd-020-dmd {nct01826487}\]) to augment the overall safety database. screening and baseline procedures are structured to avoid a gap in treatment between the double-blind study (ptc124-gd-020-dmd) and this extension study. this study may be further extended by amendment until either ataluren becomes commercially available or the clinical development of ataluren in duchenne muscular dystrophy (dmd) is discontinued.


Eligibility criteria:
inclusion criteria: * completion of study treatment in the previous phase 3, double-blind study (ptc124-gd-020-dmd). * evidence of signed and dated informed consent/assent document(s) indicating that the participant (and/or his parent/legal guardian) has been informed of all pertinent aspects of the trial. note: if the study candidate is considered a child under local regulation, a parent or legal guardian must provide written consent prior to initiation of study screening procedures and the study candidate may be required to provide written assent. the rules of the responsible institutional review board/independent ethic committee (irb/iec) regarding whether 1 or both parents must provide consent and the appropriate ages for obtaining consent and assent from the participant should be followed. * in participants who are sexually active, willingness to abstain from sexual intercourse or employ a barrier or medical method of contraception during the period of study drug administration and 6-week follow-up period. * willingness and ability to comply with scheduled visits, ataluren administration plan, study procedures, laboratory tests, and study restrictions. exclusion criteria: * known hypersensitivity to any of the ingredients or excipients of the study drug (litesse® ultratm \[refined polydextrose\], polyethylene glycol 3350, lutrol® micro f127 \[poloxamer 407\], mannitol 25c, crospovidone xl10, hydroxyethyl cellulose, vanilla, cab-o-sil® m5p \[colloidal silica\], and magnesium stearate). * ongoing participation in any other therapeutic clinical trial. * prior or ongoing medical condition (for example, concomitant illness, psychiatric condition, behavioral disorder, alcoholism, drug abuse), medical history, physical findings, electrocardiogram (ecg) findings, or laboratory abnormality that, in the investigator's opinion, could adversely affect the safety of the participant, makes it unlikely that the course of treatment or follow-up would be completed, or could impair the assessment of study results.

Keywords: duchenne muscular dystrophy dystrophinopathy nonsense mutation premature stop codon becker muscular dystrophy dmd/bmd ptc124 ataluren